Hidrohlorothiazide Aurovitas

Leaflet attached to the packaging: information for the user

Hydrochlorothiazide Aurovitas, 12.5 mg, tablets

Hydrochlorothiazide Aurovitas, 25 mg, tablets

Hydrochlorothiazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Hydrochlorothiazide Aurovitas and what is it used for
• 2. Important information before taking Hydrochlorothiazide Aurovitas
• 3. How to take Hydrochlorothiazide Aurovitas
• 4. Possible side effects
• 5. How to store Hydrochlorothiazide Aurovitas
• 6. Contents of the packaging and other information

1. What is Hydrochlorothiazide Aurovitas and what is it used for

Hydrochlorothiazide Aurovitas belongs to a group of medicines called diuretics. Diuretics increase the amount of water excreted in the urine.

Hydrochlorothiazide Aurovitas is used in adults to treat:

• fluid retention in tissues causing swelling (edema) due to heart, liver, or kidney disease;
• high blood pressure (hypertension). In this case, it can be prescribed as the only medicine or together with another medicine.

2. Important information before taking Hydrochlorothiazide Aurovitas

When not to take Hydrochlorothiazide Aurovitas

• if the patient is allergic to hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6);
• if the patient is unable to urinate (anuria);
• if the patient has severe kidney function impairment.

Warnings and precautions

Before starting treatment with Hydrochlorothiazide Aurovitas, the doctor or pharmacist should be informed:

• if the patient has had breathing or lung problems in the past (including pneumonia or fluid accumulation in the lungs). If the patient experiences severe shortness of breath or difficulty breathing after taking Hydrochlorothiazide Aurovitas, they should seek medical help immediately;
• if the patient has severe kidney or liver disease;
• if the patient has narrowing of the renal artery (narrowing of the blood vessels supplying the kidneys or a single kidney);
• if the patient has diabetes (high blood sugar levels);
• if the patient has high cholesterol or triglyceride levels;
• if the patient has a disease called systemic lupus erythematosus (also known as lupus or SLE);
• if the patient has low potassium levels in the blood (with or without symptoms such as muscle weakness, muscle cramps, or irregular heartbeat);
• if the patient has low sodium levels in the blood (with symptoms such as fatigue, confusion, muscle cramps, or without them);
• if the patient has high calcium levels in the blood (with symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness, or cramps);
• if the patient has gout attacks (uric acid crystal deposits in the joints);
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - they can occur within a few hours to a week after taking Hydrochlorothiazide Aurovitas. If left untreated, it can lead to permanent vision disturbances. If the patient has previously been allergic to penicillin or sulfonamides, they may be more prone to developing this disease;
• if the patient has allergies or asthma;
• if the patient has skin reactions, such as sun-induced rashes;
• if the patient is taking any other medicines;
• if the patient is pregnant or planning to become pregnant;
• if the patient has been diagnosed with skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially long-term use of high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). The skin should be protected from sunlight and UV radiation while taking Hydrochlorothiazide Aurovitas.

In people who chronically abuse diuretics, pseudo-Bartter syndrome may occur along with fluid retention in the body's tissues (edema).
During treatment with this medicine, it is necessary to drink sufficient fluids. Due to increased potassium loss, a potassium-rich diet should be followed (e.g., bananas, vegetables, nuts).

Exposure to sunlight or sunbed

If the patient experiences sun-induced reactions while taking this medicine, and the doctor decides to continue treatment, the skin should be protected from the sun and UV tanning beds should not be used (see also section 4 to find out what to do if these side effects occur).

Blood tests

The doctor may recommend regular blood tests during treatment to monitor kidney function, especially to control sodium, potassium, calcium, sugar (glucose), and uric acid levels in the blood.

Elderly patients (65 years and older)

When treating elderly patients, attention should be paid to possible kidney function impairment (see section 3).

Hydrochlorothiazide Aurovitas and other medicines

The doctor or pharmacist should be informed if the patient is taking, has recently taken, or may take other medicines.
There may be a need for the doctor to change the dose and/or take other precautions if the patient is taking other medicines, especially if they are taking any of the following:

• lithium (a medicine used in mental illnesses), as its combination with hydrochlorothiazide may cause lithium overdose;
• blood pressure-lowering medicines or medicines used in heart diseases [e.g., diuretics, ACE inhibitors such as ramipril, angiotensin II antagonists (like valsartan), digoxin, nitrates, and similar];
• medicines used in the treatment of mental disorders, such as depression, anxiety, schizophrenia (e.g., antidepressants, anxiolytics, antipsychotics, neuroleptics);
• medicines used in the treatment of heart rhythm disorders (e.g., quinidine, disopyramide, amiodarone, dronedarone, sotalol, digoxin);
• medicines used in the treatment of pain or inflammatory conditions, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), and aspirin;
• carbamazepine or oxcarbazepine (used in the treatment of epilepsy);
• laxatives and other laxative agents;
• corticosteroids;
• desmopressin (used in diabetes or urological disorders);
• ion exchange resins (substances used mainly in the treatment of high lipid levels in the blood);
• domperidone (preventing nausea and vomiting);
• medicines used in the treatment of malaria (e.g., halofantrine, lumefantrine);
• medicines used in allergic reactions (e.g., mizolastine, mequitazine);
• antibiotics used in the treatment of infections (e.g., amphotericin B, erythromycin, levofloxacin, moxifloxacin, spiramycin);
• iodine-based contrast agents (used in imaging tests);
• medicines used in the treatment of prostate disorders (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin);
• medicines used in the treatment of erectile dysfunction;
• medicines used in the treatment of Parkinson's disease (dopamine agonists, levodopa);
• baclofen (used in the treatment of muscle stiffness in diseases such as multiple sclerosis);
• calcium-containing tablets or other calcium supplements;
• methadone (used in the treatment of addiction to certain active substances);
• medicines used in the treatment of certain cancers (vandetanib, toremifene);
• vinpocetine (used in the treatment of neurological disorders related to aging);
• cyclosporine (used after organ transplantation, in the treatment of autoimmune diseases, or severe rheumatological or dermatological diseases).

Hydrochlorothiazide Aurovitas with food and drink

Alcohol should not be consumed while taking this medicine, as it may cause orthostatic hypotension (a sudden drop in blood pressure causing dizziness related to a change in position, e.g., standing up).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Generally, the doctor will recommend taking a different medicine instead of Hydrochlorothiazide Aurovitas, as it is not recommended during pregnancy, except in rare cases where no other treatment can be used.
This medicine passes through the placenta, and its use after the third month of pregnancy may seriously harm the fetus.
Breastfeeding
Hydrochlorothiazide passes into breast milk. This medicine should not be taken during breastfeeding, unless the doctor recommends it.

Driving and using machines

Hydrochlorothiazide Aurovitas has a minor or moderate effect on the ability to drive and use machines.
Even when used as recommended, this medicine may affect the patient's reactions. Therefore, the ability to drive vehicles and operate machines or work in locations without solid support may be limited.
This is especially important at the beginning of treatment, when the dose is increased, the medicine is changed, or taken together with alcohol.

Doping test

Hydrochlorothiazide may give a positive analytical result in a doping test.

Hydrochlorothiazide Aurovitas contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to take Hydrochlorothiazide Aurovitas

The medicine should always be taken as recommended by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Hydrochlorothiazide Aurovitas, tablets, is available in 2 strengths: 12.5 mg and 25 mg.
Edema:
Typically, the initial dose is 50 mg to 100 mg of hydrochlorothiazide per day.
The maintenance dose is usually 25 mg to 50 mg of hydrochlorothiazide per day.
Hypertension:
The currently recommended doses for hypertension are 12.5 or 25 mg per day.
Elderly patients:
When treating elderly patients (65 years and older), attention should be paid to possible kidney function impairment.

Use in children and adolescents

There is no experience with the use of hydrochlorothiazide in children and adolescents. Therefore, hydrochlorothiazide should not be given to children and adolescents.

Method of administration

Oral administration.
Tablets should be swallowed with a sufficient amount of fluid.
This medicine can be taken independently of meals.
Tablets can be divided into equal doses.

Frequency of administration

This medicine has a diuretic effect (the patient urinates more frequently). Taking this into account, it is best not to take the last dose late in the day to avoid waking up at night.
If the patient takes tablets once a day, they should be taken in the morning.

Duration of treatment

The doctor will inform the patient how long they should take this medicine.
The doctor will perform regular check-ups to ensure that the treatment has the expected effects.
In case of any questions about the duration of treatment, the doctor or pharmacist should be consulted.

Taking a higher dose of Hydrochlorothiazide Aurovitas than recommended

If nausea, drowsiness, muscle cramps, irregular heartbeat, low blood pressure (recognized by dizziness), confusion, or urinary disorders occur, the doctor should be contacted immediately.

Missing a dose of Hydrochlorothiazide Aurovitas

In case of a missed dose, it should be taken as soon as possible. A double dose should not be taken to make up for the missed dose, but treatment should be continued as recommended.

Stopping treatment with Hydrochlorothiazide Aurovitas

Treatment with Hydrochlorothiazide Aurovitas should not be stopped unless the doctor recommends it. If the patient stops treatment, their blood pressure may increase above normal (see also "Duration of treatment").
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects requiring treatment discontinuation:

In case of sun-induced reactions (skin reaction), treatment should be discontinued and the doctor or hospital emergency department should be consulted.

Very common (may affect more than 1 in 10 people):

• increased lipid levels in the blood (hyperlipidemia)
• decreased potassium levels in the blood (hypokalemia)

Common (may affect less than 1 in 10 people):

• itching rash (hives) and other skin rashes
• loss of appetite, nausea, vomiting, diarrhea
• low blood pressure when standing up from a lying position
• difficulty achieving or maintaining an erection (impotence)
• low magnesium levels in the blood (hypomagnesemia)
• low sodium levels in the blood (hyponatremia)
• increased uric acid levels in the blood (hyperuricemia)

Uncommon (may affect less than 1 in 100 people):

• acute kidney failure (significant decrease in urine excretion)

Rare (may affect up to 1 in 1000 people):

• worsening of diabetes
• increased sensitivity to sunlight
• abdominal discomfort, constipation
• liver function disorders, which may be accompanied by yellowing of the eyes and skin
• irregular heartbeat
• headache
• dizziness with a feeling of spinning
• sleep disorders
• sadness (depression)
• tingling or numbness of hands or feet (paresthesia)
• vision disturbances
• high blood sugar levels
• sugar in urine
• high calcium levels in the blood (hypercalcemia)
• low platelet count in the blood, sometimes with bleeding or bruising under the skin (thrombocytopenia)

Very rare (may affect up to 1 in 10,000 people):

• facial rash, joint pain, muscle symptoms, fever (systemic lupus erythematosus)
• vasculitis with symptoms such as rash, purpura, fever (necrotizing vasculitis)
• severe skin reaction causing rash, skin redness, blistering of the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• allergic reaction (hypersensitivity reaction)
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion)
• severe abdominal pain (pancreatitis)
• bone marrow suppression causing a decrease in red blood cells and/or too low a number of white blood cells and platelets
• red blood cell damage causing pallor, fatigue, shortness of breath, dark urine color (hemolytic anemia)
• low white blood cell count may cause fever, sore throat, or mouth sores, more frequent infections (leukopenia or possible symptoms of agranulocytosis).
• acid-base balance disorder causing disorientation, fatigue, muscle cramps, and spasms, rapid breathing (hypochloremic alkalosis).

Unknown (frequency cannot be estimated from available data):

• insufficient production of various blood cells by the bone marrow (bone marrow suppression)
• significant decrease in urine excretion (possible symptoms of kidney disorders)
• severe skin disease causing rash, skin redness, blistering of the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• fever
• muscle cramps
• weakness (asthenia)
• sudden vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - they can occur within a few hours to a week after taking Hydrochlorothiazide Aurovitas. If left untreated, it can lead to permanent vision disturbances.
• skin and lip cancer (non-melanoma skin cancer).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Hydrochlorothiazide Aurovitas

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiration date stated on the packaging after the abbreviation EXP.
The expiration date refers to the last day of the specified month.
There are no special precautions for storing the medicine.
The blister should be stored in the outer packaging to protect it from light.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Hydrochlorothiazide Aurovitas contains

• The active substance of the medicine is hydrochlorothiazide.

Hydrochlorothiazide Aurovitas, 12.5 mg, tablets
Each tablet contains 12.5 mg of hydrochlorothiazide.
Hydrochlorothiazide Aurovitas, 25 mg, tablets
Each tablet contains 25 mg of hydrochlorothiazide.

• Other ingredients are: Tablet core:lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch, cornstarch, colloidal anhydrous silica, and magnesium stearate.

What Hydrochlorothiazide Aurovitas looks like and contents of the packaging

Tablet.
Hydrochlorothiazide Aurovitas, 12.5 mg, tablets:
White or almost white, round, flat tablets with beveled edges, with the inscription "HC 12.5" on one side and a dividing line on the other. The tablet can be divided into equal doses.
Hydrochlorothiazide Aurovitas, 25 mg, tablets:
White or almost white, round, flat tablets with beveled edges, with the inscription "HC 25" on one side and a dividing line on the other. The tablet can be divided into equal doses.
Hydrochlorothiazide Aurovitas tablets are available in blister packs and HDPE containers.
Blister pack:
12.5 mg: 20, 30, 50, 60, 90, and 100 tablets
25 mg: 20, 30, 40, 50, 60, 90, and 100 tablets
HDPE container for all strengths: 500 tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer

APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua Joao De Deus 19
Amadora 2700-487
Portugal
Arrow Generiques
26 Avenue Tony Garnier
Lyon 69007
France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Hydrochlorothiazide Aurovitas
France:
Hydrochlorothiazide Arrow 12.5 mg, comprimé
Hydrochlorothiazide Arrow 25 mg, comprimé sécable
Germany:
HCT PUREN 12.5 mg/ 25 mg/50 mg Tabletten
Italy:
Idroclorotiazide Aurobindo
Netherlands:
Hydrochloorthiazide Aurobindo 12.5 mg, /25 mg, /50 mg, tabletten
Poland:
Hydrochlorothiazide Aurovitas
Portugal:
Hidroclorotiazida Generis
Spain:
Hidroclorotiazida Aurovitas 25 mg comprimidos EFG
Hidroclorotiazida Aurovitas 50 mg comprimidos

Date of last revision of the leaflet: 03/2024